MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM-P COLLARED AMISTEM-P COLLARED STD STEM SIZE 1; HIP STEM

Catalog Number	01.18.431
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	03/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No analysis could be performed since product details are not available.
Event or Problem Description
During primary hip surgery, after broaching, when the surgeon put the stem he noticed it was too long so he removed it and put a smaller stem in.When taking a post-op x-ray, it was observed that the femur was fractured.At about 10 days after the primary, the surgeon cabled the fracture and revised the stem, head, and liner.The surgery was completed successfully.It is unknown if the fracture occurred during the broaching or during the insertion of the first stem.
Event or Problem Description
During primary hip surgery, when the surgeon placed the stem, he noticed it was too long so he removed it and performed the broaching again.It was observed that the femur was fractured and the surgeon cabled it.At about 10 days after the primary, the surgeon revised the stem, head, and liner.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 10 april 2024.Lot 2007963: (b)(4) items manufactured and released on 11-dec-2020.Expiration date: 2025-11-29.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.

• Brand Name: STEM: AMISTEM-P COLLARED AMISTEM-P COLLARED STD STEM SIZE 1
• Common Device Name: HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 19132099
• Report Number: 3005180920-2024-00240
• Device Sequence Number: 17855987
• Product Code: LZO
• UDI-Device Identifier: 07630040720205
• UDI-Public: 07630040720205
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/29/2025
• Device Catalogue Number: 01.18.431
• Device Lot Number: 2007963
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 07/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/11/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female